Spurious/inaccurate penicillin allergy labels in secondary care Other
Conditions
Interventions
The proposed service model for PenA de-labelling in secondary care is as follows:
Using information captured from a structured drug allergy history and review of previous prescription records (where
Sponsors
University Hospitals Birmingham NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a current penicillin allergy label 2. Aged =18 years 3. Willing and able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Clinically unstable patients, i.e., unstable cardio-respiratory status (eg: respiratory failure, cardiac failure, pre-hepatic encephalopathy etc) 2. History of serious non-immediate systemic hypersensitivity reactions (HSRs) to penicillin 3. Documented Steven Johnson syndrome (SJS), toxic epidermal necrolysis (TENS), acute exanthematous generalised pustulosis (AEGS), erythema multiforme, haemolytic anaemia, vasculitis, acute interstitial nephritis 4. Those deemed unsuitable for medical reasons (unlikely to comply with study protocol) 5. Pregnant 6. Breastfeeding 7. Concomitant COVID-19 infection (patients from pre-surgical units and Haematology-Oncology units may be considered following recovery from COVID-19) 8. Those participating in any other research currently or those who have participated in research involving medicinal product, medical devices and/or other intervention in the preceding 6 weeks Added 11/08/2023: 9. Patients currently receiving omalizumab or those who have received omalizumab within 6 months prior to the proposed DPC 10. Patients currently taking antihistamine and unable to temporarily withdraw for the proposed DPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The behaviour, attitudes and acceptability of patients, healthcare professionals and managers regarding the use of Direct oral Penicillin Challenge (DPC) in ‘low risk’ patients, assessed using 1-1 interviews and focus groups between 6 – 18 months of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at a single timepoint: 1. The proportion of ‘low risk’ patients with a PenA label who would be eligible for a DPC, measured by applying risk stratification criteria (4-18 months) 2. The proportion of ‘low risk’ patients who would be willing and complete a DPC, measured by the number of ‘low risk’ patients who give informed consent (4-18 months) 3. The practical aspects of implementing this de-labelling programme in secondary care by investigating factors such as organisational context, treatment pathway, protocol implementation, time taken and resources (based on qualitative and quantitative methods applied in the study) 4. The potential cost-effectiveness of this service model, calculated using health economics methods comparing the cost of standard care provided to PenA patients compared to the new proposed service model between 17-22 months | — |
Countries
England, United Kingdom
Outcome results
None listed